FDA product code SIJ: Valvular Regurgitation Machine Learning-Based Notification Software
SIJ is the FDA product code for valvular regurgitation machine learning-based notification software. It is a Class II device, regulated under 21 CFR 870.2380 and reviewed by the Cardiovascular panel. Devices under SIJ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Valvular regurgitation machine learning-based notification software employs machine learning techniques to suggest the likelihood of valvular regurgitation for further referral or diagnostic follow-up.
Classification
| Field | Value |
|---|---|
| Device name | Valvular Regurgitation Machine Learning-Based Notification Software |
| Device class | Class II |
| Regulation | 21 CFR 870.2380 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for SIJ devices
openFDA lists no recalls for product code SIJ.
Frequently asked questions
What is FDA product code SIJ?
SIJ is the FDA product code for valvular regurgitation machine learning-based notification software. It is a Class II device, regulated under 21 CFR 870.2380 and reviewed by the Cardiovascular panel.
What device class is SIJ?
Class II, regulation 21 CFR 870.2380. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SIJ
- Run a recall and safety report across every SIJ manufacturer
- Watch product code SIJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.